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NCT02975271 Clinical Trial

Study of the Efficacy, Safety & Tolerability of Serlopitant for Pruritus (Itch) After Burn Injury

Burns Clinical Trial

— AUBURN  

Official title:
A Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy, Safety, and Tolerability of Serlopitant for the Treatment of Pruritus Following Burn Injury

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT02975271
Other study ID # MTI-104
Secondary ID
Status Terminated
Phase Phase 2
First received
Last updated
Start date November 2016
Est. completion date January 17, 2017

Study information
Verified date May 2021
Source Vyne Therapeutics Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Study of the Efficacy, Safety & Tolerability of Serlopitant for Pruritus (Itch) After Burn Injury

Recruitment information / eligibility
Status Terminated
Enrollment 1
Est. completion date January 17, 2017
Est. primary completion date January 17, 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility Key Inclusion Criteria: - Male or female, age 18-65 years at consent. - History of serious burn injury - Pruritus (itchiness) prior to the initial screening visit and during the screening period - Judged to be in good health in the investigator's opinion. Key Exclusion Criteria: - Prior treatment with study drug or similar drug - Pruritus (itchiness) due to another reason besides burn injury/ healing. - Presence of any medical condition or disability that, in the investigator's opinion, could interfere with the assessment of safety or efficacy in this trial or compromise the safety of the subject. - History of hypersensitivity to study drug or any of its components. - Currently pregnant or male partner of pregnant female. - Females of childbearing potential who are unable or unwilling to use adequate contraception or who are breast feeding.

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Serlopitant

• Placebo
Matching placebo

Locations
Country Name City State
United States Study Site 412 Gainesville Florida
United States Study Site 409 Lincoln Nebraska
United States Study Site 404 Phoenix Arizona
United States Study Site 413 Seattle Washington
United States Study Site 403 Tampa Florida
United States Study Site 402 Washington District of Columbia
United States Study Site 401 Winston-Salem North Carolina

Sponsors (1)
Lead Sponsor Collaborator
Vyne Therapeutics Inc.

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Change in Itch Intensity - Numeric Rating Scale Week 6
Secondary Itch Intensity Responder Rate - Numeric Rating Scale Week 6
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